510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K160545Substantially Equivalent

Gap Endo-Exo Medullary System

Orthopediatrics Canada ULC, Laval, CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K160545 is the FDA 510(k) clearance record for GAP ENDO-EXO MEDULLARY SYSTEM, a class II device, cleared for Pega Medical, Inc. on under FDA product code HSB (Rod, Fixation, Intramedullary And Accessories). FDA records list 13 510(k) clearances for ORTHOPEDIATRICS CANADA ULC, from to . As of , FDA records show no recalls naming K160545.

Clearance record

Decision date
Received
(271 days to decision)
Product code
HSB Rod, Fixation, Intramedullary And Accessories
Regulation
21 CFR 888.3020
Device class
Class II
Review panel
Orthopedic
Applicant
Pega Medical, Inc. 1111 Autoroute Chomedey, Laval, CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code HSB

Trailing 12 months
19 clearances under product code HSB in the twelve months to October 2026, March 2026 the highest month at 7.
Show the numbers
Monthly 510(k) clearances under FDA product code HSB, trailing twelve months
MonthClearances
November 20250
December 20252
January 20260
February 20261
March 20267
April 20261
May 20262
June 20265
July 20260
August 20260
September 20261
October 20260